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EXCEDRIN EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, and caffeine tablet, film coated Mechanical Servants LLC Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Drug Facts Active ingredients (in each caplet) Purposes
Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID ) Pain reliever Caffeine 65 mg Pain reliever aid Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. nonsteroidal anti-inflammatory drug
Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma
Questions? 1-800-468- Packaged and distributed by Convenience Valet with the permission of GSK Consumer Healthcare, Warren, NJ 07059 PRINCIPAL DISPLAY PANEL - 2 Caplet Packet Box EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 25 PACKETS of 2 CAPLETS EACH ®
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin, and caffeine tablet, film coated Product Information Product Type HUMAN OTC DRUG^ Item Code (Source) NDC:29485- Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CARNAUBA WAX (UNII: R12CBM0EIZ ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ 8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (UNII: FZ 989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z 65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white^ Score no s core Shape OVAL^ Size 18mm Flavor Imprint Code E **Contains Packaging
Item Code Package Description Marketing Start
Date Marketing End Date 1** NDC:29485- 8026-2 25 in 1 BOX 09/12/ 1^2 in 1 POUCH; Type 0: Not a Combination Product NDC:29485-
Mechanical Servants LLC 2 NDC:29485- 8026-1 1 in 1 BLISTER PACK 06/17/ 2^2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:29485- 8026-4 2 in 1 BLISTER PACK 02/08/ 3^2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:29485- 8026-5 2 in 1 CARTON 10/05/ 4^2 Product^ in 1 POUCH; Type 0: Not a Combination 5 NDC:29485- 8026-3 3 in 1 BLISTER PACK 06/15/ 5^2 Product^ in 1 POUCH; Type 0: Not a Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343^ 09/27/
Labeler - Mechanical Servants LLC (005530951)
Revised: 8/
